510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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HZAClass I

Methyl Green

21 CFR 864.1850 / Hematology
FDA source (opens on fda.gov)

HZA is the FDA product code for Methyl Green, a class I device type, regulated under 21 CFR 864.1850. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HZA
Device name
Methyl Green
Regulation
21 CFR 864.1850
Device class
Class I
Review panel
Hematology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code HZA

By decision year
2 clearances under product code HZA with a decision year between 1985 and 1987, 1985 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HZA by decision year
YearClearances
19851
19871

Applicants with the most clearances

Product code HZA
Applicants holding the most 510(k) clearances under product code HZA
ApplicantClearances
Sigma Chemical Co.1
Sigma Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code